Buffered NaCl Peptone EP, USP

Cat. no. U255 Buffered NaCl Peptone EP, USP, 180ml Wide Mouth Jar, 90ml 12 jars/box
Cat. no. U301 Buffered NaCl Peptone EP, USP, 500ml Polypropylene Bottle, 500ml 10 bottles/box
Cat. no. U287 Buffered NaCl Peptone with Tween® 80 EP, USP, 250ml Polycarbonate Bottle, 200ml 12 jars/box

INTENDED USE

Hardy Diagnostics Buffered NaCl Peptone EP is an isotonic agent recommended for use as a diluent in performing microbial examination of nonsterile products. The solution is used in the food, water and wastewater, pharmaceutical and cosmetic industries for microbial limits testing and enumeration procedures. Buffered NaCl Peptone EP is also recommended by the European Pharmacopoeia (EP) for the microbial examination of nonsterile products and meets the harmonization requirements of the U.S. Pharmacopeia (USP), EP and Japanese Pharmacopoeia (JP).(6,10-13,16)

This product is not intended to be used for the diagnosis of human disease.

SUMMARY

Buffered NaCl Peptone Water is a rinsing solution and pre-enrichment medium recommended as a diluent for the homogenization of samples for enumeration and microbial limits testing. It is used in the preparation of samples to dilute water-soluble products and non-fatty water insoluble products, and to promote the recovery of sub-lethally damaged Salmonella spp. The pre-enrichment medium is buffered, free of inhibitory agents and provides conditions for the resuscitation of cells that may have been injured by various processes of preservation.(15) Edel and Kampelmacher noted that sub-lethal injury to Salmonella may occur due to food preservation techniques such as heat, desiccation, high osmotic pressure, preservatives, or changes in pH.(7) Processes that result in pH changes are particularly important for testing items such as vegetable specimens, which have a low buffering capacity.

The composition of Buffered NaCl Peptone EP meets the harmonized U.S. Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), as well as the Indian Pharmacopoeia (IP), standards for use as a diluent in performing microbial examination of nonsterile products.(6,8-13,16)

Hardy Diagnostics Buffered NaCl Peptone EP contains peptone as a source of carbon, nitrogen, vitamins and minerals. Sodium chloride helps to maintain osmotic balance and the phosphate buffer system prevents bacterial cell damage due to changes in pH.

For Cat. no. U287, Tween® 80 is added to the formulation to neutralize disinfectant residues and aid in the suspension of substances. Neutralization of these residues reduces their inhibitory effect which would ultimately result in lowering of microbial count. Phenolic disinfectants and hexachlorophene are neutralized by Tween® 80.

FORMULA

Ingredients per liter of deionized water:*

Buffered NaCl Peptone EP (Cat. no. U255, U301)
Disodium Phosphate 7.2gm
Sodium Chloride 4.3gm
Monopotassium Phosphate 3.6gm
Peptone 1.0gm

In additon, Buffered NaCl Peptone with Tween® 80 EP (Cat. no. U287) contains:

Tween® 80 5.0gm

Final pH 7.0 +/- 0.2 at 25ºC.

* Adjusted and/or supplemented as required to meet performance criteria.

STORAGE AND SHELF LIFE

Storage: Upon receipt store at 2-30ºC. away from direct light. Media should not be used if there are any signs of deterioration, discoloration, contamination, or if the expiration date has passed. Product is light and temperature sensitive; protect from light, excessive heat, moisture, and freezing.

PRECAUTIONS

PROCEDURE

Method of Use: For use as a dilution buffer, rinsing solution and homogenization pre-enrichment medium for the preparation of microbial suspensions. Consult listed references or the appropriate regulatory guidelines for more specific information on the correct procedure for use.(1-3,5,6,8-13)

INTERPRETATION OF RESULTS

Observe colonies subcultured to an appropriate selective and/or differential medium for typical colonial morphology.

LIMITATIONS

Do not suspend cultures containing bacteria in dilution buffer for more than 30 minutes at room temp as cell death or multiplication may occur.

MATERIALS REQUIRED BUT NOT PROVIDED

Standard microbiological supplies and equipment such as loops, swabs, applicator sticks, other culture media, incinerators, and incubators, etc., as well as serological and biochemical reagents, are not provided.

QUALITY CONTROL

Test Organisms Inoculation Method* Incubation Results
Time Temperature Atmosphere
Buffered NaCl Peptone EP (Cat. no. U255, U301)
Escherichia coli
ATCC® 8739
J 48 hrs 30-35°C Aerobic Growth
Staphylococcus aureus
ATCC® 6538
J 48 hrs 30-35°C Aerobic Growth
Buffered NaCl Peptone with Tween® 80 EP (Cat. no. U287)
Staphylococcus aureus
ATCC® 6538
J 24 hrs 30-35°C Aerobic Growth
Pseudomonas aeruginosa
ATCC® 9027
J 24 hrs 30-35°C Aerobic Growth
Bacillus subtilis
ATCC® 6633
J 24 hrs 30-35°C Aerobic Growth
Candida albicans
ATCC® 10231
J 24 hrs 30-35°C Aerobic Growth
Aspergillus brasiliensis
ATCC® 16404
J 24 hrs 30-35°C Aerobic Growth

USER QUALITY CONTROL

Physical Appearance

Hardy Diagnostics Buffered NaCl Peptone EP should appear clear and colorless.

Hardy Diagnostics Buffered NaCl Peptone with Tween® 80 EP should appear clear to slightly hazy, with no precipitate or debris.

REFERENCES

1. American Public Health Association. Standard Methods for the Examination of Dairy Products, APHA, Washington, D.C.

2. APHA Technical Committee on Microbiological Methods for Foods. Compendium of Methods for the Microbiological Examination of Foods, APHA, Washington, D.C.

3. American Public Health Association. Standard Methods for the Examination of Water and Wastewater, APHA, Washington, D.C.

4. Anderson, N.L., et al. 2005. Cumitech 3B; Quality Systems in the Clinical Microbiology Laboratory, Coordinating ed., A.S. Weissfeld. American Society for Microbiology, Washington, D.C.

5. Association of Official Analytical Chemists. Official Methods of AnalysissmAOAC, Washington, D.C.

6. Clontz, Lucia. 2009. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements. RCR Press. Taylow and Francis Group. Boca Raton, FL.

7. Edel and Kampelmacher. 1973. Bull. W.H.O.; 48:167.

8. European Pharmacopoeia. 2008. European Directorate for the Quality of Medicine.

9. Indian Pharmacopoeia. 1997. Ministry of Health and Family Welfare. Govt. of India. Vol. 2.

10. Japanese Pharmacopoeia. 2001. The Ministry of Health, Labour and Welfare. Fourteenth Edition.

11. The Official Compendia of Standards. USP-NF. United States Pharmacopeial Convention, Rockville, MD.

12. The Official Compendia of Standards. USP General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. USP-NF. United States Pharmacopeial Convention Inc., Rockville, MD.

13. The Official Compendia of Standards. USP General Chapter <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. USP-NF. United States Pharmacopeial Convention Inc., Rockville, MD.

14.Quality Assurance for Commercially Prepared Microbiological Culture Media, M22. Clinical and Laboratory Standards Institute (CLSI - formerly NCCLS), Wayne, PA.

15. Sadovski. 1977. J. Food Technol.; 12:85.

16. Sutton, Scott. 2006. The Harmonization of the Microbial Limits Test - Absence of Specified Organisms. The Microbiology Network. www.microbiol.org/white.papers/WP.USP.62.htm.

ATCC is a registered trademark of the American Type Culture Collection.

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